Circular 25/2021/TT-BYT stipulates the reporting and statistical regime for the pharmaceuticals-cosmetics sector issued by the Minister of Health.

CIRCULAR

REGULATIONS ON REPORTING AND STATISTICAL SYSTEM IN THE FIELD OF PHARMACEUTICALS AND COSMETICS

Pursuant to the Law on Statistics dated November 23, 2015;

Pursuant to Decree No. 94/2016/NĐ-CP dated July 1, 2016 of the Government detailing and guiding the implementation of certain provisions of the Law on Statistics;

Pursuant to Decree No. 85/2017/NĐ-CP dated July 19, 2017 of the Government stipulating the structure, tasks, and powers of centralized statistical organizations and ministries' statistical systems;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues this Circular regulating the reporting and statistical system in the field of pharmaceuticals and cosmetics.

Article 1. Scope of Regulation

This Circular regulates the reporting and statistical system for collecting statistical information within the statistical index system in the healthcare sector concerning drugs (including chemical drugs, herbal drugs, vaccines, biological products except in vitro diagnostic reagents), drug raw materials (including semi-finished herbal products, except herbs), and cosmetics.

Article 2. Applicability

This Circular applies to agencies, units implementing the reporting and statistical system in the field of pharmaceuticals and cosmetics; agencies, organizations, and individuals related to the statistical work in the field of pharmaceuticals and cosmetics, including:

1. Units under and affiliated with the Ministry of Health.

2. Provincial Departments of Health and Municipal Departments of Health directly under the Central Government (hereinafter referred to as Department of Health).

3. Healthcare sectors of ministries and central-level agencies (hereinafter referred to as Sectoral Healthcare).

4. Production and business establishments of drugs, drug raw materials, and cosmetics (hereinafter referred to as production and business establishments) and agencies, organizations, and individuals related to the statistical work in the field of pharmaceuticals and cosmetics.

Article 3. Contents of the Reporting and Statistical System in the Field of Pharmaceuticals and Cosmetics

1. Reporting forms, including:

a) Form and instructions for recording reporting and statistics in the field of pharmaceuticals and cosmetics for the Department of Health as specified in Appendix I attached hereto;

b) Form and instructions for recording reporting and statistics in the field of pharmaceuticals and cosmetics for production and business establishments as specified in Appendix II attached hereto;

c) Form and instructions for recording reporting and statistics in the field of pharmaceuticals and cosmetics for Sectoral Healthcare as specified in Appendix III attached hereto;

d) Form and instructions for recording reporting and statistics in the field of pharmaceuticals and cosmetics for units under and affiliated with the Ministry of Health as specified in Appendix IV attached hereto.

2. Reporting Period

The reporting period for statistics is a fixed time frame prescribed for the reporting entity to reflect the results of activities through statistical data according to the criteria in the reporting form. The reporting period for statistics is calculated based on the Gregorian calendar, including:

a) Mid-year report: Calculated from January 1 to June 30 of the reporting period;

b) Annual report: Calculated from January 1 to December 31 of the reporting period;

c) Ad hoc report: In cases where ad hoc reports are required to fulfill state management requirements, the requesting agency must propose in writing, specifying the reporting period, deadline for submission, and specific reporting criteria.

3. Reporting Units

The reporting unit is units under and affiliated with the Ministry of Health; Department of Health; Sectoral Healthcare, and production and business establishments specifically noted in the upper right corner of each reporting form.

4. Receiving Unit and Reporting Deadline:

a) Receiving unit: Specifically noted on the right side of each form below the reporting unit;

b) Reporting deadline: Specifically noted in the upper left corner of each form.

5. Method of Submitting Reports

By written form until the Ministry of Health implements electronic reporting via software.

Article 4. Organization of Implementation

1. Reporting Units:

a) Shall comply with full, accurate, and timely reporting as prescribed in this Circular and bear legal responsibility for the reported content;

b) Shall review, resubmit reports and related information upon request of the receiving unit.

2. Drug Administration:

a) To take the lead and coordinate with relevant agencies and units to implement this Circular;

b) To take the lead and coordinate with relevant agencies and units to review the reporting and statistical system in the field of pharmaceuticals and cosmetics as stipulated in this Circular to propose amendments and supplements when there are difficulties or inconsistencies, or when necessary, to ensure compliance with reality;

c) To be the focal point for receiving, consolidating, analyzing statistical data in the field of pharmaceuticals and cosmetics, and submitting them to the Department of Planning and Finance for consolidation and publication as prescribed;

d) To be responsible for monitoring, guiding, inspecting, and reporting on the implementation of this Circular.

3. Department of Planning and Finance:

a) To be the focal point for promptly disseminating comprehensive and transparent pharmaceutical and cosmetic statistical information based on data compiled and provided by the Drug Administration;

b) To coordinate with the Drug Administration in guiding, inspecting, and auditing the implementation of regulations on statistics in the field of pharmaceuticals and cosmetics.

4. Department of Health and Sectoral Healthcare are responsible for organizing the collection, consolidation, and reporting of data as prescribed in Article 3 of this Circular.

5. Information Technology Agency is responsible for leading and coordinating with the Drug Administration and relevant units to apply information technology and deploy reporting software in statistical work in the field of pharmaceuticals and cosmetics.

Article 5. Effective Date

This Circular takes effect from February 1, 2022.

During implementation, if any difficulties or obstacles arise, agencies, organizations, and individuals are requested to report to the Ministry of Health (Drug Administration) for consideration and resolution./.